BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC FEMORAL SIZE 2, LEFT

    MDR report key: 16844502 · Received May 1, 2023

    Report

    Report Number
    1038671-2023-00514
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    January 1, 2016
    Report Date
    January 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265654
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING. THE REPORTED FEMORAL LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-010-06-0220 - 4114527 - LOGIC CC FEMORAL SIZE 2, LEFT. 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 02-012-60-1680 - LOGIC STEM EXT 16MM X 80MM. 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 65 YO FEMALE PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING WITH PERSISTENT THIGH PAIN RELATED TO MICROMOTION OF FEMORAL STEM WITH INCOMPLETE FIXATION. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2016. INITIALLY TRIED STRENGTHENING EXERCISES AS PATIENT TREATMENT. THE PATIENT WAS REVISED ON (B)(6) 2021 ALONG WITH MEDICATION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566240 LOGIC CC FEMORAL SIZE 2, LEFT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862265654

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other| R SEE H10